vaccine therapy followed by biological therapy in treating patients with stage iii or stage iv melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. combining vaccine therapy with biological therapy may kill more tumor cells. purpose: this phase ii trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage iii or stage iv melanoma.

objectives: * determine the clinical response rate and immune response in hla-a2 positive patients with stage iii or iv melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (mart-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with cd40-ligand and interferon gamma, followed by interleukin-2 in vivo. * determine the toxicities of this regimen in these patients. outline: this is a multicenter study. patients undergo leukapheresis to harvest autologous dendritic cells (adcs). melanoma peptides (mart-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto adcs, which are also treated ex vivo with cd40-ligand, interferon gamma, interleukin-4, sargramostim (gm-csf), and candida albicans skin test reagent. patients receive each melanoma peptide pulsed adc vaccine separately via 3 successive 10 minute infusions on day 1. patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 21-41 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic melanoma * measurable disease after attempted curative surgery * unresectable stage iii or iv uveal melanoma * metastatic mucosal melanoma * hla-a2.1 positive * no disease progression following high dose interleukin-2 (600,000 or 720,000 iu/kg every 8 hours) patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 75,000/mm\^3 * hemoglobin at least 9.0 g/dl * no coagulation disorders hepatic: * bilirubin no greater than 2.0 mg/dl renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no myocardial infarction within the past 6 months * patients with documented or suspected coronary artery disease must undergo stress thallium test * no major cardiovascular illness pulmonary: * no major pulmonary illness immunologic: * hiv negative * hepatitis b surface antigen negative * hepatitis c antibody negative * no history of uveitis or autoimmune inflammatory eye disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no major systemic infection * no other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer prior concurrent therapy: biologic therapy: * see disease characteristics * no prior mart-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens chemotherapy: * at least 1 month since prior chemotherapy for melanoma endocrine therapy: * no concurrent steroid therapy radiotherapy: * at least 1 month since prior radiotherapy for melanoma surgery: * see disease characteristics other: * at least 1 month since prior adjuvant therapy for melanoma * at least 1 month since other prior therapy for melanoma

Keywords: stage iii melanoma stage iv melanoma recurrent melanoma